Vaginal Drug Delivery Device and Vaginal Diagnostic Device

ABSTRACT

The present invention is related to a vaginal drug delivery device and to a vaginal diagnostic device that comprises a first and second rigid member, wherein the first and/or second rigid member comprises a reservoir holding a medicament to be delivered, an opening, and a pump for pumping said medicament out of said opening, and/or wherein the first rigid member and/or second rigid member comprises a diagnostic device for performing an intravaginal diagnosis or measurement therefor. The device further comprises a first flexible member and flexible part, wherein at least one of the first flexible member and the flexible part is at least partially elastic having an elasticity such that the device can be squeezed from an extended shape to a collapsed shape. The device is pre-biased to assume the extended shape when little to no external force is being applied thereto. Furthermore, the device assumes a shape substantially corresponding to the extended shape when the device is inserted with the squeezed rigid member first, so that these naturally unfold in the formix posterior vaginae.

The present invention is related to a vaginal drug delivery device andto a vaginal diagnostic device. The present invention is also related toa combination of a vaginal drug delivery device and a vaginal diagnosticdevice.

Within the context of the present invention, a vaginal drug deliverydevice is a device configured for delivering drugs while inside thevagina. Similarly, a vaginal diagnostic device is configured forperforming a diagnostic or measurement function while inside the vagina.

Vaginal drug delivery devices are known in the art. For instance, alow-dose contraceptive vaginal ring, known as Nuvaring®, is manufacturedfrom poly(ethylene-co-vinyl acetate). This ring releases hormones toprovide contraception protection.

This known ring is made from a flexible material allowing the ring to besqueezed to transform a shape of the ring for allowing the ring to beinserted into the vagina. The hormones are added to the flexiblematerial in such a manner that the ring slowly releases the hormonesafter placement in the vagina.

A drawback of this known device is that the release of drugs is notentirely constant in time. Furthermore, the delivery rate of the drugsis continuous and has only one dosage. It is independent of variablefactors such as age and weight. Obviously it cannot be switched off oron, other than being inserted or removed. It does not have theprogrammability (schedule) or adjustability (dose) possibility. Afurther drawback exists due to the fact that the drug delivery does notdepend on ambient conditions and more in particular the physiologicalstate of the user, e.g. whether the user is a fast/slow metabolizer, orthe moment in the fertility cycle. Consequently, an inappropriate amountof drugs may be delivered.

An object of the invention is to provide a device with which theabovementioned disadvantages can be prevented or minimized.

According to the invention, this object is achieved with the vaginaldrug delivery and/or diagnostic device as claimed in claim 1. Thisdevice comprises a first rigid member having a first and second end, asecond rigid member having a third and fourth end, a first flexiblemember coupled between the first and third ends, and a flexible partcoupled between the second and fourth ends. According to the presentinvention, the first rigid member and/or second rigid member comprises areservoir holding a medicament to be delivered, an opening, and a pumpfor pumping the medicament out of said opening. Additionally oralternatively, the first rigid member and/or second rigid membercomprises a diagnostic device for performing an intravaginal diagnosisor measurement therefore.

Furthermore, at least one of the first flexible member and the flexiblepart is at least partially elastic, wherein the elasticity of the atleast one of the first flexible member and the flexible part is suchthat 1) the device can be squeezed to transform a shape of the devicefrom an extended shape to a collapsed shape for allowing the device tobe inserted into a vagina of a user, 2) the device is pre-biased toassume the extended shape when little to no external force is beingapplied thereto, said extended shape corresponding to a substantiallyoval or annular ring shape, and 3) the device assumes a shapesubstantially corresponding to the extended shape when the device isinserted into the vagina with the squeezed rigid parts first. The rigidparts will assume a natural position in the deepest part of the vagina,the fornix posterior vaginae.

The invention proposes to divide the vaginal drug delivery and/ordiagnostic device into rigid and flexible components, wherein thefunctional parts of the drug delivery and/or diagnostic mechanism, whichare mostly sensitive and/or rigid components, are incorporated in therigid component(s) and wherein the flexible components allow the deviceto be squeezed to transform the shape of the device to allow a user toplace the device inside the vagina. Here, it is noted that theelasticity of the device, originating from at least one of the firstflexible member and the flexible part, causes the device tosubstantially return to its original shape. This shape is important asthe device should not or hardly be felt by the user when placed insidethe vagina. Furthermore, the shape should be such that it should not orhardly be noticeable during coitus. It is therefore preferable when anouter surface of the device is substantiality smooth. In addition, asmooth outer surface prevents or limits irritation of the vaginal wall.

In an embodiment, the at least one of the first flexible member and theflexible part is at least partially made from an elastic material.

In an embodiment, the first flexible member acts as a hinge to allow thefirst and second rigid members to move with respect to each other. Inthis embodiment, the first flexible member is made of an elastic andflexible material, whereas the flexible part is merely flexible havinglittle to no elasticity. Hence, in this embodiment, the first and secondrigid members can be moved to each other by applying an external force.At the same time, the flexible part flexes to accommodate this movement.Once the external force is removed, the device springs back to itsoriginal form due to the elasticity of the first flexible member.

The flexible part could comprise a second flexible member, a thirdflexible member, a fourth flexible member, a third rigid member having afifth and sixth end, and a fourth rigid member having a seventh andeight end. Here, the second flexible member is coupled in between thesecond end and the fifth end, the third flexible member is coupled inbetween the fourth end and the seventh end, and the fourth flexiblemember is coupled in between the sixth end and the eight end.

In an alternative embodiment, the flexible part is at least partiallyelastic. For example, at least one of the second, third, and fourthflexible member is at least partially made from an elastic material.Hence, in this embodiment the flexible part could also provide apre-bias to assume the extended shape.

Furthermore, the second, third, or fourth rigid member may comprise asource of electrical energy, such as a battery, for providing electricalenergy to the pump and/or diagnostic device. The device may furthercomprise a first flexible electrical connection in between the energysource and the pump and/or diagnostic device. This first flexibleelectrical connection can be accommodated in the flexible member(s)arranged in between the pump and/or diagnostic device and the rigidmember that holds the electrical energy source.

The pump and the energy source can be accommodated in different rigidmembers among the first, second, third, and fourth rigid members, and/orthe diagnostic device and the energy source can be accommodated indifferent rigid members among the first, second, third, and fourth rigidmembers.

As stated before, functional parts of the drug delivery or diagnosticmechanism can be accommodated in the rigid components of the device. Forexample, the first, second, third, or fourth rigid member may comprise acontroller for controlling the pump and/or diagnostic device.Additionally or alternatively, the first, second, third, or fourth rigidmember may comprise a sensor for measuring biochemical compounds and/ormedicines, such as a hormone levels like oestradiol, Luteinizing hormone(LH), and progesterone or glucose. The sensor can also be used tomeasure other biochemical parameters and/or medication levels.Additionally or alternatively, the first, second, third, or fourth rigidmember may comprise such sensor, wherein the controller is configuredfor controlling the pump in dependence of a measurement performed bythis sensor. The measurement can be done physicochemically, or as assay,in the cervical mucus or transudate of the vaginal wall.

The device may further comprise a second flexible electrical connectionin between the sensor and the controller, and/or a third flexibleelectrical connection in between the energy source and the controller,and/or a fourth flexible electrical connection in between the controllerand the pump and/or diagnostic device, wherein the second, third, and/orfourth flexible electrical connection is at least partly accommodated inthe first, second, third, and/or fourth flexible member.

The first, second, third, and/or fourth rigid member and the first,second, third, and/or fourth flexible member can be formed, preferablyby injection moulding, using a respective material composition, andwherein the material composition(s) used for the rigid members differsfrom the material composition(s) used for the flexible members. Here,the couplings between the flexible and rigid members can be fixed,preferably formed during the injection moulding of the flexible and/orrigid members.

The material composition used for at least one of the rigid memberscomprises one or more of the materials of the group consisting of:polyolefin, ABS (acrylonitrile butadiene styrene), PA (polyamide), PBTcopolyesters (polybutylene terephthalate), polyethylene, polypropylene,polystyrene, polyester, polyester (PLA and other biosorbable plastics),polycarbonate, polyvinyl chloride, polyethersulfone, polysulfone, andpolyetheretherketone.

The material composition used for at least one of the flexible membersmay comprise one or more of the materials of the group consisting of:LSR (liquid silicone rubber), thermoplastic elastomers (TPE, TPU),thermoset elastomers such as silicone rubber, butadiene rubber,fluoropolymers, poly(p-xylylene) (parylene), and polyacrylate such aspoly(methyl methacrylate) (PMMA).

To allow a user to easily place the device inside the vagina, it isadvantageous if the device in the extended shape extends around acentral axial axis, wherein an outer diameter of the device, determinedin a plane perpendicular to the axial axis, lies in a range between 50and 70 mm, and more preferably between 55 and 65 mm, and wherein aninner diameter of the device, determined in a cross section parallel tothe axial axis, lies in a range between 4 and 8 mm. In an embodiment,the device has a ring shape with a substantially constant outerdiameter. Moreover, an internal diameter of the device, determined in aplane perpendicular to the axial axis, can be smaller near at least oneof the rigid members. The part of the device containing functional partsof the drug delivery or diagnostic mechanism, such as the medicamentcontainer or pump. will naturally reside in the deeper part of thevagina, close to the cervix uteri.

At least one of the rigid members in isolation may have a bendingstrength such that when a force of 0.5N is applied at a forceapplication point that is at a distance of 20 mm relative to a fixationpoint at which the rigid member is held fixed, a bending angle, whichcorresponds to a rotation angle related to a rotation about the fixationpoint of a line that extends between the fixation point and the forceapplication point due to the application of the force, does not exceed10 degrees.

At least one of the flexible members in isolation may have a bendingstrength such that when a force of 0.5N is applied at a forceapplication point that is at a distance of 20 mm relative to a fixationpoint at which the rigid member is held fixed, a bending angle, whichcorresponds to a rotation angle related to a rotation about the fixationpoint of a line that extends between the fixation point and the forceapplication point due to the application of said force, exceeds 30degrees.

The vaginal drug delivery and/or diagnostic device may further comprisea transmitter configured for wireless transmission of measurement datacorresponding to measurements performed by the sensor and/or measurementdata or diagnosis information outputted by the diagnostic device.Additionally or alternatively, the device may comprise a receiver forwirelessly receiving control commands for remote control of at least oneof the pump, the sensor, and the diagnostic device. The receiver andtransmitter may be combined into a single transceiver unit.

Next, the invention will be described in more detail referring to theappended figures, wherein:

FIG. 1 schematically illustrates an embodiment of a device in accordancewith the present invention;

FIG. 2 illustrates a possible shape of a device in accordance with thepresent invention in an extended and collapsed state;

FIG. 3 illustrates the device of FIG. 2 showing a possible location ofsome of the components of the device of FIG. 1;

FIG. 4 illustrates the device of FIG. 3 being inserted into the vagina;and

FIG. 5 illustrates different possible shapes of a device in accordancewith the present invention in an extended and collapsed state.

FIG. 1 schematically illustrates an embodiment of a device 1 inaccordance with the present invention. This device comprises a container2 for holding a medicament through an opening (not illustrated) ofdevice 1. A pump 3 is used for pumping the medicament out of theopening. A sensor 4 is used to determine the flow rate of medicamentthrough the opening. The flow sensor may act indirectly by measuring thefilling level of container 2.

Device 1 comprises a further sensor 5 that measures for example ahormone level or glucose, or a medicine. Information from sensor 4 andfrom sensor 5 is fed to a controller 6 which controls pump 3. Hence, itis possible to deliver drugs inside the vagina based on hormone levelsmeasured inside the vagina and/or the level inside container 2.

Device 1 could be embodied as a device for delivering GnRH for ovulationinduction of the Kallmann syndrome (or of other hypo-hypo conditions).In this case, sensor 5 could be configured for measuring oestradioland/or LH (in the cervical mucus or transudate of the vaginal mucosa)for prediction of the pending ovulation and discontinuation of the drugdelivery. Device 1 could also be embodied as a device for deliveringinsulin. In this case, sensor 5 could be configured for measuring theglucose level (in the transudate of the vaginal mucosa) allowingcontroller 6 to subsequently change the dose of insulin. Sensor 5 couldalso be embodied as a sensor that measures a level of medicine in thebody via transudate of the mucosa. This information could be used bycontroller 6 to subsequently change the vaginal drug delivery if needed.Especially in known non-compliant patients (e.g. depression and otherchronic diseases) a constant and therapeutic level of medication is ofvital importance.

A battery 7 is used to provide electrical power to any of the componentsin device 1 that require electrical power. It should be appreciated thatother forms of energy could equally be used.

Device 1 may further comprises a diagnostic function 8 that is coupledto a sensor 9, which sensor measures a hormone level, a physiologicalparameter, or medicine. This diagnostic function could be used forovulation prediction, or monitoring of an assisted reproduction cycle(IVF, ovulation stimulation, artificial insemination) where monitoringthe (increase of) the hormone levels like E2, LH and progesterone todiagnose the pending ovulation or moment of ovulation induction (withHCG) is of vital importance. Alternatively, device 1 could be measuringthe glucose level (in the transudate of the vaginal mucosa) to determinethe need for insulin delivery for diabetes treatment. Here, diagnosticfunction 8 can be embodied as a processor and may be integrated withcontroller 6. Based on measurements obtained by sensor 9, diagnosticfunction 8 performs a diagnosis or solely processes the measurements.This information is fed back to controller 6, which may control pump 3in dependence of the output of diagnostic function 8. Alternatively oradditionally, controller 6 supplies data from sensor 4, sensor 5, and/ordiagnostic function 8 to a transceiver 10 for wirelessly transmittingthe data to a receiver preferably external to the body of the user.Moreover, device 1 may be limited to performing the measurements and/ormaking the diagnosis. For instance, device 1 may be configured to onlymeasure the glucose level and to transmit the corresponding measurementdata to an external device. This external device may display themeasurement data and/or may comprise or control an insulin pump. Thisapproach can be extended to other types of measurements as well.

In general, transceiver 10 allows device 1 to communicate results to anoutside computer or handheld device. This data transfer may be relatedto the drug delivery function only (dosage, frequency, timing), thusindicating the rate of compliance to therapy, or to the diagnosticfunction only (prediction of moment of ovulation, measurement of glucoselevel or level of medication), or to the integrated functions of both.Additionally or alternatively, transceiver 10 may also be used toreceive data from an external transmitter to control the functionalityof device 1. Such data could for instance comprise control data thatinstructs controller 6 to start/stop delivering the medicament usingpump 3 or to start/stop performing a diagnosis by diagnostic function 8.

It should be apparent that not every function or component is required.For instance, diagnostic function 8 and sensor 9 could be omitted ifsuch functionality is not required or desired. Moreover, transceiver 10could be embodied as a transmitter or receiver only.

FIG. 2 illustrates a possible shape of a device in accordance with thepresent invention in an extended (left) and collapsed state (right).This shape comprises a first rigid member 101, a second rigid member102, a first flexible member 111, and a flexible part 110. The firstrigid member 101 has a first end 301 and a second end 302. The secondrigid member 102 also has a first end 303 and a second end 304. Here,first flexible member 111 is made of an elastic material and comprises arecess 105 to allow first and second rigid member 101, 102 to movetowards each other when device 100 is squeezed into the collapsed state.

According to the invention, the functional parts of the drug deliveryand/or diagnostic mechanism are incorporated into the rigid members 101,102, whereas the (electrical) interconnect can be accommodated in theflexible member 111 or flexible part 110.

FIG. 3 illustrates the device of FIG. 2 showing an exemplary arrangementof some of the components of the device of FIG. 1. Here, it can be seenthat the functional parts of the drug delivery mechanism, i.e. battery7, controller 6, pump 3, reservoir 2, and sensor 5 are incorporated infirst rigid member 101 and second rigid member 102. Moreover, an opening120 can be identified through which the medicament held in reservoir 2is pumped out by pump 3. This opening will be located at such a place onthe outer perimeter of the ring to guarantee optimal contact with thevaginal mucosa. Furthermore, an electrical interconnect 121 can be seenthat connects the various components to each other and to battery 7.

In FIG. 3, a transceiver may be incorporated in controller 6 or mayalternatively be arranged as a separate component in first rigid member101. This transceiver allows data communication between controller 6 andexternal systems or devices for remote control or for exchanging datasuch as measurement data.

First rigid member 101 may be provided with an opening or membrane toenable sensor 5 to perform a predefined measurement. Similar openings ormembranes can be provided if additional sensors are used which may ormay not be arranged in first rigid member 101. These openings will belocated at such places on the outer or inner perimeter of the ring toguarantee optimal contact with the vaginal mucosa or cervical mucus.

A possible manner to fabricate the device shown in FIG. 3 is describednext. First, the relevant components of the drug delivery mechanism arearranged inside a mold. To this end, these components can be arranged inone or more rigid shells to protect these components from the remainingprocessing steps. Furthermore, the electrical interconnect, whichpreferably is flexible, is also arranged inside the mold. More inparticular, all the components are electrically connected at this point.Thereafter the mold is closed, and a suitable material or materials isinjection molded. In this manner, flexible part 110 and flexible member111 are formed and surround the electrical interconnect. This samematerial ensures that the various shells, if used, become fixedlyconnected to flexible part 110 and flexible member 111. Hence, in thisfabrication process, a rigid member may comprise a rigid shell that isgenerally coated or covered with the material that is used for flexiblemember 111 and/or flexible part 110. Alternatively, flexible member 111can be made from a different material. For instance, flexible member 111is made from elastic material whereas flexible part 110, and thereforethe material that may cover the shells of rigid members 101, 102, ismerely flexible. Such material for flexible member 111 can be placedinside the mold prior to injection molding.

It should be noted that the various components for the drug delivery anddiagnosis mechanism need not be fully arranged inside the rigid members.In some cases, the components may extend into the flexible and/orelastic members or parts of the device.

FIG. 4 illustrates the device of FIG. 3 being inserted into the vagina.Here, a body 200 of the user is shown indicating the urethra 201, thevagina 202, and the uterus 203. Prior to inserting device 100, it issqueezed to transform the shape into the collapsed state. Thereafter,the user inserts device 100 with the squeezed rigid parts first intovagina 202, and moves device 100 close to cervix uteri 204 or fornixposterior vaginae 205, where device 100 is released. Due to itselasticity, device 100 regains its original shape, at least to asubstantial extent. Due to its shape and size, device 100 rests againstthe vaginal wall. This positioning allows appropriate measurements to beperformed. Moreover, this position ensures that little to no irritationor pain is observed by the user and that any impact of device 100 oncoitus is minimized.

FIG. 5 illustrates different possible shapes of a device in accordancewith the present invention in an extended and collapsed state. Comparingthese shapes to the shape indicated in FIG. 2 it can be observed thatflexible part 110 has been replaced by a second flexible member 112, athird flexible member 113, a fourth flexible member 114, a third rigidmember 103, and a fourth rigid member 104.

In FIG. 5, the shapes in the top half indicate the extended shapes,whereas the shapes in the bottom half represent the correspondingcollapsed states. The shape to be used depends on the amount offunctional parts to be accommodated in the rigid members and therelative sizes of these components.

In the above, the invention has been disclosed by referring toembodiments thereof. It should be appreciated by the person skilled inthe art that various modifications are possible without deviating fromthe invention, the scope of which is defined by the appended claims.

1. A vaginal drug delivery and/or diagnostic device, comprising: a firstrigid member having a first and second end; a second rigid member havinga third and fourth end; a first flexible member coupled between thefirst and third ends; a flexible part coupled between the second andfourth ends; wherein the first rigid member and/or second rigid membercomprises: a reservoir holding a medicament to be delivered, an opening,and a pump for pumping said medicament out of said opening; and/or adiagnostic device for performing an intravaginal diagnosis ormeasurement therefor; wherein at least one of the first flexible memberand the flexible part is at least partially elastic; wherein theelasticity of the at least one of the first flexible member and theflexible part is such that: the device can be squeezed to transform ashape of the device from an extended shape to a collapsed shape forallowing the device to be inserted into a vagina of a user; the deviceis pre-biased to assume the extended shape when little to no externalforce is being applied thereto, said extended shape corresponding to asubstantially oval or annular ring shape; the device assumes a shapesubstantially corresponding to the extended shape when the device isplaced and released at or near the fornix posterior vaginae of a user.2. The vaginal drug delivery and/or diagnostic device according to claim1, wherein an outer surface of the device is substantiality smooth. 3.The vaginal drug delivery and/or diagnostic device according to claim 1,wherein said at least one of the first flexible member and the flexiblepart is at least partially made from an elastic material.
 4. The vaginaldrug delivery and/or diagnostic device according to claim 1, wherein theflexible part comprises: a second flexible member; a third flexiblemember; a fourth flexible member; a third rigid member having a fifthand sixth end; a fourth rigid member having a seventh and eight end;wherein the second flexible member is coupled in between the second endand the fifth end; wherein the third flexible member is coupled inbetween the fourth end and the seventh end; and wherein the fourthflexible member is coupled in between the sixth end and the eight end.5. The vaginal drug delivery and/or diagnostic device according to claim1, wherein the second, third, or fourth rigid member comprises a sourceof electrical energy, such as a battery, for providing electrical energyto said pump and/or diagnostic device, said device further comprising afirst flexible electrical connection in between said energy source andsaid pump and/or diagnostic device, said first flexible electricalconnection being accommodated in the flexible member(s) arranged inbetween the pump and/or diagnostic device and the rigid member thatholds the electrical energy source.
 6. The vaginal drug delivery and/ordiagnostic device according to claim 5, wherein the pump and the energysource are accommodated in different rigid members among the first,second, third, and fourth rigid members; and/or wherein the diagnosticdevice and the energy source are accommodated in different rigid membersamong the first, second, third, and fourth rigid members.
 7. The vaginaldrug delivery and/or diagnostic device according to claim 1, wherein thefirst, second, third, or fourth rigid member comprises a controller forcontrolling said pump and/or diagnostic device.
 8. The vaginal drugdelivery and/or diagnostic device according to claim 1, wherein: thediagnostic device comprises a sensor for measuring biochemical compoundsand/or medicines, such as a hormone levels like oestradiol, luteinizinghormone (LH), and progesterone or glucose, and/or other biochemicalparameters and/or medication levels; and/or the first, second, third, orfourth rigid member comprising such sensor, said controller beingconfigured for controlling said pump in dependence of a measurementperformed by said sensor.
 9. The vaginal drug delivery and/or diagnosticdevice according to claim 1, said device further comprising a secondflexible electrical connection in between said sensor and saidcontroller, and/or a third flexible electrical connection in betweensaid energy source and said controller, and/or a fourth flexibleelectrical connection in between said controller and said pump and/ordiagnostic device, wherein said second, third, and/or fourth flexibleelectrical connection is at least partly accommodated in the first,second, third, and/or fourth flexible member.
 10. The vaginal drugdelivery and/or diagnostic device according to claim 1, wherein thefirst, second, third, and/or fourth rigid member and the first, second,third, and/or fourth flexible member is formed, preferably by injectionmoulding, using a respective material composition, and wherein thematerial composition(s) used for the rigid members differs from thematerial composition(s) used for the flexible members; wherein thecouplings between the flexible and rigid members are preferably fixed,preferably formed during the injection moulding of the flexible and/orrigid members; and/or wherein the material composition used for at leastone of the rigid members preferably comprises one or more of thematerials of the group consisting of: polyolefin, ABS (acrylonitrilebutadiene styrene), PA (polyamide), PBT copolyesters (polybutyleneterephthalate), polyethylene, polypropylene, polystyrene, polyester,polyester (PLA and other biosorbable plastics), polycarbonate, polyvinylchloride, polyethersulfone, polysulfone, and polyetheretherketone;and/or wherein the material composition used for at least one of theflexible members preferably comprises one or more of the materials ofthe group consisting of: LSR (liquid silicone rubber), thermoplasticelastomers (TPE, TPU), thermoset elastomers such as silicone rubber,butadiene rubber, fluoropolymers, poly(p-xylylene) (parylene), andpolyacrylate such as poly(methyl methacrylate) (PMMA).
 11. The vaginaldrug delivery and/or diagnostic device according to claim 1, said devicein the extended shape extending around a central axial axis; wherein anouter diameter of the device, determined in a plane perpendicular tosaid axial axis, lies in a range between 50 and 70 mm, and morepreferably between 55 and 65 mm; wherein an inner diameter of thedevice, determined in a cross section parallel to the axial axis, liesin a range between 4 and 8 mm; wherein the device preferably has a ringshape with a substantially constant outer diameter and/or wherein aninternal diameter of the device, determined in a plane perpendicular tosaid axial axis, is preferably smaller near at least one of the rigidmembers.
 12. The vaginal drug delivery and/or diagnostic deviceaccording to claim 1, wherein at least one of the rigid members inisolation has a bending strength such that when a force of 0.5N isapplied at a force application point that is at a distance of 20 mmrelative to a fixation point at which the rigid member is held fixed, abending angle, which corresponds to angle of rotation related to arotation about the fixation point of a line that extends between thefixation point and the force application point due to the application ofsaid force, does not exceed 10 degrees.
 13. The vaginal drug deliveryand/or diagnostic device according to claim 1, wherein at least one ofthe flexible members in isolation has a bending strength such that whena force of 0.5N is applied at a force application point that is at adistance of 20 mm relative to a fixation point at which the rigid memberis held fixed, a bending angle, which corresponds to a rotation anglerelated to a rotation about the fixation point of a line that extendsbetween the fixation point and the force application point due to theapplication of said force, exceeds 30 degrees.
 14. The vaginal drugdelivery and/or diagnostic device according to claim 1, furthercomprising a transmitter configured for wireless transmission ofmeasurement data corresponding to measurements performed by the sensorand/or measurement data or diagnosis information outputted by thediagnostic device.
 15. The vaginal drug delivery and/or diagnosticdevice according to claim 1, further comprising a receiver forwirelessly receiving control commands for remote control of at least oneof the pump, the sensor, and the diagnostic device. The receiver andtransmitter may be combined into a single transceiver unit.